NRX Pharmaceuticals Inc.

The FDA Office of Generic Drugs has issued NRx Pharmaceuticals a Discipline Review Letter for its preservative-free ketamine generic, requiring only minor administrative changes and updated stability data following a positive bioequivalence determination. Regulators signaled support for resolving remaining questions within the current review cycle, targeting approval in summer 2026. The stock has risen sharply recently; analysts expect strong revenue growth in 2026 and a return to profitability. NRx is also preparing an NDA to update labeling for depression and suicidality. » More on de.investing.com

NRx Pharmaceuticals has appointed Weinberg & Company as its new independent auditor for the fiscal year ending December 31, 2025; the audit committee approved the change on November 20, and Salberg was dismissed around November 24. Weinberg & Company previously audited Dura Medical, a company acquired by the subsidiary Hope Therapeutics, and there were no consultations or disagreements between NRx and Weinberg in recent reporting periods. NRx also reported Q3 2025 revenue of about $240,000 after the Dura Medical acquisition, an operating loss of $4.0 million, and cash and cash equivalents of $7.2 million (potentially $10.3 million if a subscription right is exercised), giving a funding runway to about Q3 2026, or Q2 2026 if the additional subscription is used. » More on de.investing.com